A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)
This study is for adults who have already taken part in a previous clinical trial for Graves' Disease, where they received a medicine called IMVT-1402. It's a 'long-term extension study,' meaning it continues to follow these participants to see how the medicine works over a longer time. The main goals are to find out if IMVT-1402 continues to be effective in managing Graves' Disease and if it remains safe when used for an extended period. Participants will be grouped based on their Graves' Disease status when they finished the earlier study. This helps researchers gather more complete information about the potential benefits and any side effects of the treatment.
At a glance
What is this study about?
Graves' Disease is a condition where your immune system mistakenly attacks your thyroid gland, making it produce too many hormones. This can cause various symptoms like a fast heartbeat, weight loss, and anxiety. Doctors are always looking for new and better ways to help people manage this condition.
This study is about a medicine called IMVT-1402, which is being tested as a potential treatment for Graves' Disease. This particular study is called a 'long-term extension study.' This means it's not starting with new patients, but rather continuing to follow people who have already been taking part in an earlier study for IMVT-1402. The main goal is to understand how well the medicine works and if it is safe over a longer period of time.
By continuing to observe these patients, researchers can gather important information that can't be learned in shorter studies. This includes seeing if the medicine keeps working effectively, if there are any long-term side effects, and how it impacts people's health over months or even years. This kind of information is vital to help doctors and patients make informed decisions about future treatments for Graves' Disease.
Key takeaways
- This study is for adults already in an IMVT-1402 trial for Graves' Disease.
- It's a longer-term follow-up to check safety and effectiveness.
- Participants will continue receiving IMVT-1402 medicine.
- Regular health checks and tests will be part of the study.
- The aim is to gather more complete information about the treatment.
- Participation is voluntary, and you can withdraw anytime.
Who may be eligible?
This study is specifically for adults who have already been taking part in one of two previous clinical trials for Graves' Disease. These earlier studies were called IMVT-1402-2502 or IMVT-1402-2503.
To be considered for this long-term study, you must have successfully completed your previous IMVT-1402 study. This means you didn't stop taking the study medicine early and didn't have any serious problems that caused you to leave the study before it finished. Your study doctor will know if you meet these specific requirements.
There might be other detailed reasons why someone could or couldn't join, which your study team would discuss with you. These are usually in the study plan, known as the 'protocol.'
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult (18 years or older)?
- Have you taken part in Study IMVT-1402-2502 or Study IMVT-1402-2503 for Graves' Disease?
- Did you complete your previous study without stopping the medicine early?
- Were there no reasons that caused you to leave your previous study?
- Are you prepared for ongoing medical check-ups?
What does participation involve?
If you join this study, it means you'll continue to receive the IMVT-1402 medicine you were taking in the previous trial. You'll be placed into one of three groups based on how your Graves' Disease was doing at the end of your last study. This helps the researchers learn more specifically about the medicine's effects in different situations.
You will have regular appointments at the clinic for check-ups. During these visits, the study team will monitor your health, ask about any symptoms or side effects you might be experiencing, and carry out various tests. These tests might include blood samples to check your thyroid hormone levels and other general health markers. The total length of your participation will depend on the study plan, but it's designed to be a longer-term follow-up.
Potential risks and benefits
Locations (131)
- Site Number - 1561Verified postcodePhoenix, United States
- Site Number - 1519Verified postcodePhoenix, United States
- Site Number - 1530Verified postcodeTucson, United States
- Site Number - 1510Verified postcodeConcord, United States
- Site Number - 1587Verified postcodeHuntington Beach, United States
- Site Number - 1554Verified postcodeLos Angeles, United States
- Site Number - 1588Verified postcodeOrange, United States
- Site Number - 1559Verified postcodeSan Francisco, United States
- Site Number - 1558Verified postcodeSanta Clarita, United States
- Site Number - 1552Verified postcodeTorrance, United States
- Site Number - 1533Verified postcodeAurora, United States
- Site Number -1514Verified postcodeEnglewood, United States
Common questions
What is the main goal of this study?
The main goal is to find out how well the medicine IMVT-1402 works and if it's safe for people with Graves' Disease over a longer period of time.
Who can take part in this study?
This study is only for adults who have already completed a specific previous study (IMVT-1402-2502 or IMVT-1402-2503) for Graves' Disease.
What is Graves' Disease?
Graves' Disease is a condition where your immune system causes your thyroid gland to make too many hormones, leading to various symptoms.
Will I get a new medicine in this study?
No, you will continue to receive the IMVT-1402 medicine you were taking in the previous study.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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